Issuance of ISO13485 for the manufacture of animal-free ultrapure chitosan

SYNO-3501-SYNOLYNE-SIGLE

16.06.2015

Liège-Herstal (Belgium) 16 June 2015 – Synolyne Pharma has announced the qualification of its new GMP manufacturing zone and the issuance of the ISO13485 certificate for the production of animal-free ultrapure chitosan. This follows an extensive program by Synolyne Pharma aimed at improving its infrastructure and implementing its Quality Management System.

Medical devices manufactured from biomaterials of animal or human origin tend to raise concerns because of the potential risks to human health. Such risks include contamination by bacteria, viruses or other transmissible agents. Synolyne Pharma specializes in the design and the development of safe and efficient implants and therapeutic solutions that are based on “chitosan”, which is a biopolymer that is 100% animal-free and commercialized under the “Vegetech insideTM” brand.

« We are delighted to see our new brand “Vegetech insideTM “ becomes a reality as a result of the installation of our new production zone and the issuance of the ISO13485 certificate » stated Houtaï Choumane, CEO and Managing Director of Synolyne Pharma. « With this accomplishment, our company has become the only one in the world that is able to manufacture – in a reliable and controlled way – the animal-free ultrapure chitosan. This is a biopolymer that can be valorized on the market of medical implants » added Mr. Choumane.
This certification comes following the development program that was initiated by Synolyne Pharma to provide the market with highly innovative medical devices that are dedicated to patients who suffer from arthritis, a disabling illness that affects over 100 million people worldwide.
« The issuance of the ISO13485 follows the achievement of the qualification phase of our new GMP cleanrooms. This enables us to prepare the regulatory file of our products that are intended for intra-articular injection and which will be entering the clinical investigation phase very shortly » explained Dr. Pierre Douette, COO of Synolyne Pharma.

Beyond the interest regarding its own rheumatology products, these two steps also enable Synolyne Pharma to guarantee unprecedented robustness, accuracy and purity to the manufacturing process of its « Vegetech insideTM» biomaterials, in turn making them essential for the development of a new generation of class III medical devices for regenerative medicine.

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